510(k) Report

Devices descending from K912026

6 later devices reach Delfia (R) 17 -OH-Progesteron Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K042424Delfia Neonatal 17A-OH-Progesterone KitWallac OY20040—
+1K042425Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY20044—
+2K081922Autodelfia Neonatal 17A-OH-Progesterone KitWallac OY20091—
+2K060452Accuwell 17-Alpha-Hydroxyproesterone Enzyme Immunoassay with Models 6015XX-EcahNeo-Genesis20070—
+2K050960Modification to: Autodelfia Neonatal 17A-OH-Progesterone L KitWallac OY20050—
+3K100682GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001UWallac OY20100—